A customer in (b)(6) notified biomérieux that they observed out of range high results when using vidas® hcg 60 tests (ref.30405, lot 1008107910), in the context of an external quality control.As this was an external quality control sample, there is no patient involved.The customer obtained the following results when testing the liquichek immunoassay plus control bio-rad, level 1 with vidas hcg 60 tests, lot 1008107910: on (b)(6) 2020: 5.39 mui/ml.On (b)(6) 2020: 5.55 mui/ml, 6.29 mui/ml, 6.07 mui/ml, 5.35 mui/ml, 6.02 mui/ml.On (b)(6) 2020: 5.13 mui/ml.The expected range for this qc sample level 1 was 4.23 (3.51 - 4.949) rilibäk range (17% deviation).It is reported that calibrations performed on (b)(6) 2020 and on (b)(6) 2020 were valid.A biomérieux internal investigation has been initiated.Note: reference 30405 is not registered in the united states.The u.S similar device is product reference 30405-01 (k141133).
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